Status:
COMPLETED
A Study to Investigate the Effect of SB-705498 on Chronic Cough
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
Eligibility Criteria
Inclusion
- Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
- Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- Non-smoker for at least 6 months with a pack history \<5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- Body weight \> 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
- Capable of giving written informed consent.
- Agree to use contraception listed as acceptable
- Normal 12-lead ECG at screening.
- Chronic cough (Part B only)
- Good general health, apart from chronic cough (part B only), as determined by a responsible physician.
Exclusion
- A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- Positive pre-study drug/alcohol screen.
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- History of regular alcohol consumption within 6 months of the study.
- Exposure to more than four new chemical entities within 12 months prior to the start of the study.
- Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study.
- Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to study.
- known history of lung cancer
- current treatment with oral corticosteriods or other immunosupressive agents
- FEV1 less than 80% of predicted value at screening
- Any subject who does not reach C5 following 250uM oral capsaicin
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01476098
Start Date
April 1 2011
End Date
January 1 2012
Last Update
December 1 2016
Active Locations (1)
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1
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ